A Study on Reducing Opioid Use After Minimally Invasive Ankle Surgery

Zhejiang University

Status: Not yet enrolling

Conditions: Ankle Sprain; Ankle (Ligaments); Instability (Old Injury); Talus Osteochondral Defect; Non-Opioid Pain Management; Opioid Analgesia

Treatments: Drug: Non-opioid analgesic regimen; Drug: Opioid Analgesic Regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT07154433

2025-0286

Details and patient eligibility

About

Study Title Effect of a Postoperative Multimodal Analgesic Protocol Predominantly Based on Non-Opioid Medications vs Opioid-Based Analgesia on Pain After Minimally Invasive Ankle Surgery: A Noninferiority Randomized Clinical Trial

Purpose This study aims to compare the pain control effect and side effects of non-opioid versus opioid medications in patients undergoing ankle arthroscopy. The goal is to find a safer analgesic strategy to reduce opioid use and related risks (e.g., addiction, respiratory depression) while maintaining effective postoperative pain management.

Design Study Type: Prospective, randomized controlled trial. Participants: 110 adults (18-65 years) scheduled for ankle arthroscopy and Mini-open ankle surgery under general anesthesia.

Interventions:

Experimental Group: Non-opioid regimen (celecoxib + acetaminophen). Control Group: Opioid regimen (oxycodone + acetaminophen). Assessments: Pain scores (NRS) at 2 hours,6 hours,12 hours, 24 hours, and days 2-6 postoperatively; Area under the curve (AUC\_{0-24}) of Numerical Rating Scale (NRS) pain intensity scores from 0-24 hours.adverse events (e.g., nausea, constipation); The total consumption of additional rescue opioids, expressed as oral morphine equivalent dose (OME); patient satisfaction.

Key Eligibility Able to provide informed consent. ASA physical status I-II. BMI 16-32 kg/m². Exclusion criteria: Chronic pain, opioid use history, allergies to study drugs, or severe organ dysfunction.

Benefits & Risks Benefits: Standardized analgesia management and personalized pain monitoring; potential contribution to safer clinical pain protocols.

Risks: Opioids may cause nausea, sedation, or respiratory depression; non-opioids may carry risks of gastrointestinal bleeding or liver injury. Emergency support is available for severe events.

Contact Information

For more details, contact the research team at Zhejiang University Second Affiliated Hospital:

Phone: [phone] Email: [e-mail] This trial is registered to evaluate non-opioid alternatives for ankle arthroscopy pain control, prioritizing patient safety and evidence-based care.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-65 years old. Scheduled for elective ankle arthroscopy under general anesthesia. American Society of Anesthesiologists (ASA) physical status I or II. Body mass index (BMI) 16-32 kg/m². Able to understand and sign the informed consent form. Willing and able to comply with study procedures, including follow - up visits and outcome assessments.

Exclusion criteria

• History of chronic pain (pain lasting >3 months) or current use of opioid medications within the past 3 months.

Known allergies or contraindications to study medications (celecoxib, acetaminophen, oxycodone, tramadol, dezocine).

Severe cardiovascular, hepatic, renal, or respiratory dysfunction (ASA ≥ III). History of substance abuse, alcohol dependence, or significant psychiatric disorders.

Pregnant or breastfeeding women. Participation in another clinical trial within the past 30 days. Unstable medical conditions that may interfere with study participation or outcome assessment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Non-Opioid Analgesia Group

Experimental group

Description:

Participants in this group will receive a multimodal non - opioid analgesic regimen. The treatment includes celecoxib(Flurbiprofen axetil) and acetaminophen(Jingxin (a Chinese pharmaceutical company)), aiming to provide effective pain relief while reducing the use of opioids and minimizing associated risks such as addiction, respiratory depression, and gastrointestinal adverse events during the perioperative period of ankle arthroscopy.

Treatment:

Drug: Non-opioid analgesic regimen

Opioid Analgesia Group

Active Comparator group

Description:

This group will be administered an opioid - based regimen with oxycodone - acetaminophen(Parecoxib). It represents the standard clinical practice for postoperative pain control and serves as a reference to compare the efficacy and safety of the non - opioid regimen in managing pain after ankle arthroscopy.

Treatment:

Drug: Opioid Analgesic Regimen